Mechelen, Belgium; 23 February 2010 - Galapagos NV (Euronext: GLPG) announced today that it has completed Phase I clinical trials for GLPG0259, a novel mechanism-of-action candidate drug being developed for rheumatoid arthritis (RA). These results support the design of a Phase II study planned to start later this year, where the efficacy of the novel candidate drug will be assessed in RA patients. Galapagos will present detailed results of GLPG0259 and other programs during an R&D Update scheduled for 19 March 2010.
The Phase I studies for GLPG0259 have shown a good safety profile in healthy volunteers and confirm a once-daily oral dosing regimen. Furthermore, the studies have confirmed the feasibility of combining GLPG0259 with methotrexate (the current standard treatment for RA) in future trials. A similar safety and PK profile was observed for the capsule formulation of GLPG0259, which will be used in the Phase II efficacy trial in RA patients scheduled to begin in the third quarter of 2010.
"This latest clinical study further demonstrated the safety and once-daily dosing of GLPG0259 in healthy volunteers and sets us on course to initiate an extended trial in rheumatoid arthritis patients," said Onno van de Stolpe, CEO of Galapagos. "We are very pleased with how this program is progressing and excited that we are on track to start the assessment of the first Galapagos-based candidate drug in patients later this year."
About Galapagos' R&D update and webcast presentation
Galapagos invites analysts, investors and journalists to attend an R&D update meeting in which an overview of the Company's clinical and pre-clinical pipeline progress will be given. The meeting will take place at Galapagos' Paris research site, located at 102 Avenue Gaston Roussel 93230 Romainville, France, starting at 13.00 CET on 19 March 2010.
Galapagos management will present the R&D strategy, the latest information on Galapagos' discovery and development programs and an update to its clinical and pre-clinical portfolio. Those who wish to attend the meeting in person should confirm their attendance via email to email@example.com.
Galapagos will also hold a conference and live audio webcast of this meeting starting at 13.00 CET on 19 March 2010. Click here to access the live audio webcast. To participate in the conference call, please call +32 2290 1791 ten minutes prior to commencement. A question and answer session will follow the presentation of the results. The archived webcast also will be available for replay shortly after the live presentation.
About MAPKAPK5 and candidate drug GLPG0259
Target MAPKAPK5 is a new starting point for the treatment of rheumatoid arthritis (RA). Galapagos discovered and validated the key role of this target in the RA disease process, using its proprietary target discovery technology. MAPKAPK5 had not been previously associated with RA; however, Galapagos has shown that it plays a key role in inflammation and in the breakdown of collagen in human cartilage. The candidate drug GLPG0259 inhibits MAPKAPK5 in human cells, and demonstrates excellent bone protection and reduced inflammation in a standard RA animal model.
GLPG0259 is a novel mechanism-of-action inhibitor of the protein kinase MAPKAPK5. It is a compound in Galapagos' internal RA program, which is part of an option agreement with Janssen Pharmaceutica. Upon the completion of a dose finding Phase II clinical trial for GLPG0259, Janssen has the exclusive option to license the program for €60 million, with further potential milestones to Galapagos of €776 million and up to double-digit royalties on global sales.
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company specialized in the discovery and development of small molecule and antibody therapies with novel modes-of-action. The Company is progressing one of the largest pipelines in biotech, with four clinical and over 40 small molecule discovery/pre-clinical programs. Through risk/reward-sharing alliances with GlaxoSmithKline, Eli Lilly, Janssen Pharmaceutica, Merck & Co. and Roche, Galapagos is eligible to receive up to €3 billion in downstream milestones, plus royalties. Together with the service operations of BioFocus and Argenta, Galapagos now has more than 640 employees and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
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